FDA Device recall Z-0671-2020
Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determin…
- FDA Device
- Class II
- terminated
- Published 2019-12-18
On 2019-12-18 the FDA classified a Class II recall of Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determin… by The Binding Site Group, citing deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Protein Kits.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0671-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-02-19 |
| Published | 2019-12-18 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | The Binding Site Group |
| Distribution | US |
Product
Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determination of C-reactive protein (CRP) concentration in serum using the Binding Site Optilite analyser. Measurement of C-Reactive Protein aids in evaluation of the amount of injury to body tissues and for evaluation of infection, tissue injury, and inflammatory disorders. This test should be used in conjunction with other laboratory and clinical findings. The Optilite C-Reactive Protein Calibrator is intended for the calibration of the Optilite C-Reactive Protein Reagent on the Optilite analyser. The Optilite C-Reactive Protein Controls are intended for use in quality control by monitoring accuracy and precision for the Optilite C-Reactive Protein Reagent.
Reason
Deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Protein Kits
Identifiers
| code_info | Model Number: NK044.OPT.A Lot 437705 UDI 05051700018449 Medical Device Listing number D317086 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Other recalls by The Binding Site Group
- Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Product Description: The EXE…
FDA Device · Class II · 2026-06-17 · The Binding Site Group - Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the SPAPLUS) (x10) REF LK018…
FDA Device · Class II · 2021-12-01 · The Binding Site Group - FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie Leichtkette (Human) kit for Roche cobas c Systems, REF: LK0…
FDA Device · Class II · 2021-07-14 · The Binding Site Group - Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A
FDA Device · Class II · 2021-02-10 · The Binding Site Group - Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four components)
FDA Device · Class II · 2020-06-03 · The Binding Site Group
All The Binding Site Group recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0671-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.